IT Quality and Validation Manager
Indianapolis, IN 
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Posted 1 day ago
Job Description

At Roche, 97,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity, and on seeing each other's differences as an advantage. To innovate healthcare, Roche has ambitious plans to keep learning and growing - and is seeking people who have the same goals for themselves.

Would you like to contribute to the RDC Global IT?

Purpose:

  • Responsible for the assessment, facilitation and verification of quality standards achieved within IT activity in accordance with the requirements of RDC corporately and any external legislative or regulatory requirements
  • To apply the specifications of the corporate and organization quality systems and quality standards to ensure that the quality of processes and delivery of IT projects and services continuously meet their specified requirements
  • Evaluates information systems, platforms and IT operating procedures according to the firm's standards and standard methodologies, create and conduct IT risk assessments, manage IT policies and standards as well as assist IT in evaluating and implementing technologies and processes to securely enable the business
  • Leads internal as well as external audit activities and ers compliance in the global IT function

Accountabilities:

  • Drive continuous improvement of the quality system to meet and sustain compliance with internal and external regulatory requirements
  • Conduct periodic quality reviews to fulfill the requirements for quality, to un-cover errors or deficiencies and to identify strengths and opportunities for improvement
  • Follow-up resolution of identified quality exposure and communication to line management of critical situations are not resolved in due course
  • Drive shifting of emphasis from 'final inspections' to 'in process reviews and controls'
  • Contribute to business decisions in the definition and assessment of IT requirements
  • Collaborate with business and IT partners to ensure RDC practices are aligned with regulatory expectations and industry standard methodologies
  • Responsible for ensuring high Quality/Compliance for all IT services, efficient organizational operations and financial transparency
  • Ensure that all IT processes fulfill the relevant regulations (e.g. RDC IT control framework, GxP, SOX, ...)
  • Liaises with Roche Compliance organization(s) to use expertise and solve fundamental issues in the interpretation of compliance aspects related to IT
  • Drives and facilitates the creation of relevant Process Descriptions, Standard Operating Procedures and Work Instructions
  • Prepares and follows up on internal authority inspections

Performance Indicators:

  • Compliance/Quality regime optimized for RDC business model
  • Compliance and Quality audits of IT do not contain unpredictable surprises
  • Transparency on Compliance, Quality or IT risks and issues
  • Continuous quality improvement plan with clear metrics
  • Projects delivered according to established and agreed RDC IT governance (PM Selection, partnership with all governance functions, Hard Gates, Documentation, etc).
  • Amount of Projects with performed System Risk Assessments, DCR, etc
  • Zero audit and compliance findings

Who you areYou will bring the following skills and experience:

  • Track record of managing IT Quality and Compliance in a CSV environment, including handling IT risks, IT Compliance & IT audits
  • Technical understanding of Quality/Compliance issues specific to one or more of the technologies in the RDC ecosystem is a requirement
  • Holds and maintains industry certifications in Compliance, Privacy & Quality e.g. ISACA and ISO
  • Detailed understanding of the relevant compliance/security as well as quality standards (e.g. ISO 2700x, GxP, SOX, Data privacy laws, GDPR, CDPA, etc.)
  • Can demonstrate the ability to communicate
  • Minimum 10 years' experience in IT Quality, IT Compliance and/or Audit
  • Minimum 5 years' experience leading people

If you are proud of contributing and feel you have the dedication to teamwork and innovation that we are seeking, then Roche is the organization for you. Every role at Roche plays a part in making a difference to patients' lives. If you want work in a hardworking team, make your mark & improve lives, apply now.

Roche embraces diversity and equal opportunity in a serious way. We are committed to building a team that represents a variety of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be.

Roche is an equal opportunity employer.

Information Technology, Information Technology > IT Compliance
Roche is an Equal Opportunity Employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.

 

Job Summary
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Experience
10+ years
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